Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia

NCT04276181 | Recruiting DMC

• 3 other identifiers: 2020-06208ALFGBG-918931ALFGBG-774951
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Tetraplegia after a cervical spinal cord injury (C-SCI) radically alters an individual's ability to perform normal activities of daily life due to paralysis in all extremities, resulting in lifelong dependence.\[1\] Traditional tendon transfer surgery has proven successful in restoring grip functions which greatly improves autonomy, but with a restricted passive opening of the hand. The number of transferrable muscles in the arm is however limited, why nerve transfer surgery is a new attractive option to further improve hand function by enabling active opening of the hand. Significant advantages of distal nerve transfers include less extensive surgical dissection, greatly reduced hospital stay, rehabilitation and restrictions, and thereby less health care use and costs. In an effort to further improve hand function and independence in patients with tetraplegia, hand surgeons at Centre for Advanced Reconstruction of Extremities (C.A.R.E.), Sahlgrenska University Hospital (SUH)/Mölndal have developed a strategy in which a nerve transfer procedure aiming to restore active opening of the hand is done prior to reconstruction of grip functions. To date, no study has compared the efficacy of this combined nerve and tendon transfer (CNaTT) procedure to traditional grip reconstruction by means of tendon transfer alone, thus constituting a major gap in the literature. The purpose of this study is therefore to fill that knowledge gap by comparing the clinical outcomes of a cohort of patients who undergo the CNaTT procedure to restore hand function, to those treated by means of tendon transfer alone.

Conditions

Spinal Cord Injury Cervical; Tendon Transfer; Nerve Transfer; Rehabilitation; Grip Function

Outcome Measures

Primary Outcomes (1)

• Cylinder test

  This test is developed at SUH and currently under reliability testing. The cylinder test assesses the patients' ability to actively grasp and release glass cylinders of varying breadth, ranging from 10 to 150 mm.

  5 minutes

Secondary Outcomes (6)

• Grip ability as measured using the Grasp and Release Test (GRT)

  20 minutes

• Grip strength will be measured with JAMAR dynamometer

  2 minutes

• Pinch grip strength will be assessed using the Pinch Gauge

  2 minutes

• Activity and participation (goal achievement and quality of life) will be measured using the Canadian Occupational Performance Measure (COPM)

  10 minutes

• Activity and participation will be measured using the Tetraplegic Upper Limb Activity Questionnaire (TUAQ).

  10 minutes

Study Arms (2)

Combined Nerve and Tendon Transfer (CNaTT) group

The surgical procedures are described in the section Detailed description

Traditional transfer procedure group

The surgical procedures are described in the section Detailed description

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tetraplegia due to a cervical spinal cord injury.

You may qualify if:

• Subjects must be between 15-55 years of age
• Subjects must be diagnosed with a spinal cord injury AIS level C5 to C7
• Time after injury ≤ 12 months
• The strength of the muscle supplied by the donor nerve (supinator) must be graded ≥ 4 according to Medical Research Council (MRC)
• The strength of musculus brachioradialis and wrist extensors must be graded ≥ 4 according to MRC (to be used in grip reconstruction)

You may not qualify if:

• Finger extensor strength ≤ MRC 1
• Evidence of lower motor neuron injury in muscles supplied by the donor nerve
• Subjects must not have any current serious or unstable illness that could interfere with the study
• Medically unstable to undergo surgery as determined by physician
• Spasticity in the forearm or hand graded \> 1 according to Modified Ashworth Scale

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Center for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital/Mölndal

Mölndal, Sweden

RECRUITING

Related Publications (13)

• Friden J, Gohritz A. Tetraplegia Management Update. J Hand Surg Am. 2015 Dec;40(12):2489-500. doi: 10.1016/j.jhsa.2015.06.003.

  PMID: 26537454 BACKGROUND

• Bunketorp-Kall L, Wangdell J, Reinholdt C, Friden J. Satisfaction with upper limb reconstructive surgery in individuals with tetraplegia: the development and reliability of a Swedish self-reported satisfaction questionnaire. Spinal Cord. 2017 Jul;55(7):664-671. doi: 10.1038/sc.2017.12. Epub 2017 Feb 21.

  PMID: 28220821 BACKGROUND

• Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.

  PMID: 15224087 BACKGROUND

• Moberg E. The present state of surgical rehabilitation of the upper limb in tetraplegia. Paraplegia. 1987 Aug;25(4):351-6. doi: 10.1038/sc.1987.63. No abstract available.

  PMID: 3627823 BACKGROUND

• Bossuyt FM, Arnet U, Brinkhof MWG, Eriks-Hoogland I, Lay V, Muller R, Sunnaker M, Hinrichs T; SwiSCI study group. Shoulder pain in the Swiss spinal cord injury community: prevalence and associated factors. Disabil Rehabil. 2018 Apr;40(7):798-805. doi: 10.1080/09638288.2016.1276974. Epub 2017 Jan 13.

  PMID: 28084832 BACKGROUND

• van Zyl N, Hahn JB, Cooper CA, Weymouth MD, Flood SJ, Galea MP. Upper limb reinnervation in C6 tetraplegia using a triple nerve transfer: case report. J Hand Surg Am. 2014 Sep;39(9):1779-83. doi: 10.1016/j.jhsa.2014.06.017. Epub 2014 Jul 23.

  PMID: 25063391 BACKGROUND

• O'Grady KM, Power HA, Olson JL, Morhart MJ, Harrop AR, Watt MJ, Chan KM. Comparing the Efficacy of Triple Nerve Transfers with Nerve Graft Reconstruction in Upper Trunk Obstetric Brachial Plexus Injury. Plast Reconstr Surg. 2017 Oct;140(4):747-756. doi: 10.1097/PRS.0000000000003668.

  PMID: 28609352 BACKGROUND

• Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.

  PMID: 25767422 BACKGROUND

• Bertelli JA, Ghizoni MF. Nerve transfers for elbow and finger extension reconstruction in midcervical spinal cord injuries. J Neurosurg. 2015 Jan;122(1):121-7. doi: 10.3171/2014.8.JNS14277.

  PMID: 25343189 BACKGROUND

• Friden J, Lieber RL. Reach out and grasp the opportunity: reconstructive hand surgery in tetraplegia. J Hand Surg Eur Vol. 2019 May;44(4):343-353. doi: 10.1177/1753193419827814. Epub 2019 Feb 11.

  PMID: 30744461 BACKGROUND

• Bertelli JA, Tacca CP, Ghizoni MF, Kechele PR, Santos MA. Transfer of supinator motor branches to the posterior interosseous nerve to reconstruct thumb and finger extension in tetraplegia: case report. J Hand Surg Am. 2010 Oct;35(10):1647-51. doi: 10.1016/j.jhsa.2010.07.012.

  PMID: 20888500 BACKGROUND

• Friden J, Reinholdt C, Turcsanyii I, Gohritz A. A single-stage operation for reconstruction of hand flexion, extension, and intrinsic function in tetraplegia: the alphabet procedure. Tech Hand Up Extrem Surg. 2011 Dec;15(4):230-5. doi: 10.1097/BTH.0b013e31821b5896.

  PMID: 22105635 BACKGROUND

• Wangdell J, Bunketorp-Kall L, Koch-Borner S, Friden J. Early Active Rehabilitation After Grip Reconstructive Surgery in Tetraplegia. Arch Phys Med Rehabil. 2016 Jun;97(6 Suppl):S117-25. doi: 10.1016/j.apmr.2015.09.025.

  PMID: 27233586 BACKGROUND

Central Study Contacts

Lina Bunketorp-Käll, PhD

CONTACT

+46709723101; lina.bunketorp-kall@neuro.gu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 19, 2020
• Study Start: January 26, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

SE (1)